SPRIX Drug Patent Profile
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Which patents cover Sprix, and what generic alternatives are available?
Sprix is a drug marketed by Zyla and is included in one NDA.
The generic ingredient in SPRIX is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sprix
A generic version of SPRIX was approved as ketorolac tromethamine by MYLAN on May 16th, 1997.
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Summary for SPRIX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Patent Applications: | 4,893 |
| Drug Prices: | Drug price information for SPRIX |
| What excipients (inactive ingredients) are in SPRIX? | SPRIX excipients list |
| DailyMed Link: | SPRIX at DailyMed |
Pharmacology for SPRIX
| Drug Class | Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Paragraph IV (Patent) Challenges for SPRIX
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SPRIX | Nasal Spray | ketorolac tromethamine | 15.75 mg/spray | 022382 | 1 | 2012-03-12 |
US Patents and Regulatory Information for SPRIX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zyla | SPRIX | ketorolac tromethamine | SPRAY, METERED;NASAL | 022382-001 | May 14, 2010 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for SPRIX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Zyla | SPRIX | ketorolac tromethamine | SPRAY, METERED;NASAL | 022382-001 | May 14, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Zyla | SPRIX | ketorolac tromethamine | SPRAY, METERED;NASAL | 022382-001 | May 14, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SPRIX
See the table below for patents covering SPRIX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Italy | MI912024 | ⤷ Sign Up | |
| Italy | 1250691 | COMPOSIZIONI TERAPEUTICHE PER SOMMINISTRAZIONE INTRANASALE COMPRENDENTI KETOROLAC. | ⤷ Sign Up |
| Greece | 3019012 | ⤷ Sign Up | |
| Germany | 69206345 | ⤷ Sign Up | |
| Japan | H05194215 | THERAPEUTIC COMPOSITION FOR NARIAL ADMINISTRATION CONTAINING 5-BENZOYL-2,3-DIHYDRO-1H-PYRROLIDINE- 1-CARBOXYLIC ACID | ⤷ Sign Up |
| Denmark | 0524587 | ⤷ Sign Up | |
| Austria | 130758 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SPRIX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1534313 | C 2015 055 | Romania | ⤷ Sign Up | PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728 U O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NA |
| 1534313 | 76/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730 |
| 1534313 | CR 2015 00072 | Denmark | ⤷ Sign Up | PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730 |
| 1534313 | 92923 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730 |
| 1534313 | 15C0090 | France | ⤷ Sign Up | PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728 |
| 1534313 | 300784 | Netherlands | ⤷ Sign Up | PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730 |
| 1534313 | CA 2015 00072 | Denmark | ⤷ Sign Up | PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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